A Phase 1 Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors

Официальное название

A Phase 1 Dose Escalation and Expansion Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific Antibody-Drug Conjugate, in Participants With Select, Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors

Обзор

This is a first in human (FIH), Phase 1, dose escalation and expansion study in select solid tumors. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B).

Подробное описание

This is a FIH, Phase 1, open-label, multicenter, multiple-dose, dose escalation and expansion study. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B). NEOK001 is a bispecific B7-H3 x ROR1 exatecan antibody-drug conjugate (ADC) that will be administered intravenously once every cycle.

Вмешательства

• Препарат NEOK001
  Escalating doses of NEOK001
• Препарат NEOK001 RDE
  Recommended Dose of NEOK001 for Expansion

Первичные конечные точки

• Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs) [Срок оценки: 21 Days]
• Part A: Incidence and Severity of Adverse Events (AEs) [Срок оценки: Through study completion, estimated as 32 months]
• Part B: Investigator Assessment of Objective Response Rate (ORR) [Срок оценки: Through study completion, estimated as 32 months]
• Part B: Duration of Response (DOR) [Срок оценки: Through study completion, estimated as 32 months]

Вторичные конечные точки (3)

• Part B: Incidence of AEs [Срок оценки: Through study completion, estimated as 32 months]
• Maximum Concentration (Cmax) [Срок оценки: 21 days]
• Terminal Elimination Half Life (T1/2) [Срок оценки: 21days]

Критерии участия

Критерии включения

• Participants must have locally advanced or metastatic disease in a select tumor type, for which no standard therapy is available.
• Participants must have at least 1 measurable target lesion based on RECIST v1.1.
• Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Participants must have adequate hematologic, hepatic, and renal function.
• Participants should have available archived tumor tissue from their most recent biopsy.

Критерии исключения

• Participant's most recent systemic anti-cancer treatment was an ADC with a topoisomerase 1-inhibitor payload component.
• Participants with known symptomatic central nervous system (CNS) metastases or any evidence of leptomeningeal disease or evidence of unstable CNS metastases, even if asymptomatic.
• Participants with a known history of interstitial lung disease (ILD) requiring steroid treatment, or for whom suspected ILD cannot be ruled out by imaging at screening.
• Participants with clinically severe pulmonary compromise due to intercurrent pulmonary illness and/or pulmonary disorder requiring supplemental oxygen or any prior pneumonectomy.
• Participants with a QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 8 центров

• Memorial Sloan Kettering Cancer Center — New York
• SCRI Oncology Partners — Nashville
• NEXT Oncology — Austin
• NEXT Oncology — Dallas
• MD Anderson Cancer Center — Houston
• NEXT Oncology — Houston
• NEXT Oncology — San Antonio
• NEXT Oncology — Fairfax

Идентификаторы

NCT: NCT07612176 · NEOK001-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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